Apitoxin is a new biological drug for pain & inflammation and arthritis, approved by the Korean FDA on May 3, 2003 after 14 years of preclinical, animal, and phase I, II & III clinical studies

Anti-inflammatory action, neurohormonal stimulation and immunomodulation

1. Summary Dr. CMH. Kim and the International Pain Institute formulated a biological drug, named Apitoxin (Apitox, pure bee venom) and obtained approval for Phase II clinical studies (Investigational New Drug, US FDA IND #3132, March 3, 1989) To develop a new drug in the United States is very expensive and takes on average of 13 to 17 years, at an approximate cost of US$900 million. Thus, I went to Korea in 1989, and there with a small pharmaceutical company began the development of this drug as a joint venture (market limited in Korea only). It took over 14 years to complete preclinical (animal, toxicity and safety studies), phase I (human toxicity and safety), phase II (efficacy), and phase III studies (multicenter--four University Medical Centers, completed in November 2002. Apitoxin has been approved as a new drug by the Korean FDA (May 3, 2003 KFDA #354), and was launched on September 2, 2003 in Korea. Today many clinicians use Apitoxin for chronic painful diseases for their everyday practice. In the USA, I am seeking a partnership, licensing or joint venture to apply for the final phase III clinical trial (pain & inflammation, arthritis). 2. Drug development process It costs an average of $ 900,000,000 and over 12years to release a new drug on the market. The pharmaceutical companies research and test about 10,000 - 30,000 different materials, but usually only one is successfully released to the public. Most of them cannot pass through the restricted and confident the testing criteria, but once the substance is approved it will provide an opportunity for a better quality of life for the patients.

Registered

1. KOREA: Registered 10/30/2003 #0405128 2. JAPAN: Applied 4/27/2001 #P2001-130722 Expected to be registered by 9/2006 3. USA: Applied 7/13/2000 #09/615,437 Applied 10/22/2003 #10/690,772 Expected to be registered by 10/2006 4. EGYPT: New drug applied in 12/2003 Expected to be approved by 12/2006 by Egyptian Government

Seeking for partnership, joint venture or venture capital fund for completion of the US FDA CBER (Biological Division) final clinical trial (phase III).